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Application of Raman spectroscopy in monoclonal antibody producing continuous systems for downstream process intensification
Author(s) -
Yilmaz Denizhan,
Mehdizadeh Hamidreza,
Navarro Dunie,
Shehzad Amar,
O'Connor Michael,
McCormick Philip
Publication year - 2020
Publication title -
biotechnology progress
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.572
H-Index - 129
eISSN - 1520-6033
pISSN - 8756-7938
DOI - 10.1002/btpr.2947
Subject(s) - raman spectroscopy , process analytical technology , monoclonal antibody , process engineering , process (computing) , process control , downstream (manufacturing) , biochemical engineering , environmental science , process optimization , biological system , downstream processing , computer science , chemistry , materials science , chromatography , chemical engineering , antibody , engineering , biology , bioprocess , physics , operations management , environmental engineering , optics , immunology , operating system
Monoclonal antibodies (mAbs) are biopharmaceuticals produced by mammalian cell lines in bioreactors at a variety of scales. Cell engineering, media optimization, process monitoring, and control strategies for in vitro production have become crucial subjects to meet increasing demand for these high value pharmaceuticals. Raman Spectroscopy has gained great attention in the pharmaceutical industry for process monitoring and control to maintain quality assurance. For the first time, this article demonstrated the possibility of subclass independent quantitative mAb prediction by Raman spectroscopy in real time. The developed model estimated the concentrations of different mAb isotypes with average prediction errors of 0.2 (g/L) over the course of cell culture. In situ Raman spectroscopy combined with chemometric methods showed to be a useful predictive tool for monitoring of real time mAb concentrations in a permeate stream without sample removal. Raman spectroscopy can, therefore, be considered as a reliable process analytical technology tool for process monitor, control, and intensification of downstream continuous manufacturing. The presented results provide useful information for pharmaceutical industries to choose the most appropriate spectroscopic technology for their continuous processes.